Problem reporting

Health product complaint process

• Reporting complaints about health products
• Health Product Complaint Form (FRM-0317)

Medical devices

• Medical device complaint
• Recall Reporting for Medical Devices:
  • Medical device initial recall reporting form (FRM-0360A)
  • Medical device final recall reporting form (FRM-0360B)
• Guide to Recalls of Medical Devices (GUI-0054)
• Guidance on Investigation of Reported Medical Device Problems (GUI-0065)
• Mandatory Problem Reporting for Medical Devices
  • Preliminary Report Form (FRM-0237)
  • Final Report Form (FRM-0238)
  • Preliminary and Final Report Form (FRM-0255)

If you want to report an adverse reaction or a problem about another type of product, please visit Health Canada's Adverse Reaction Reporting web page.

Materials, activities or any other matters under the Assisted Human Reproduction Act

• Reporting a complaint for the Assisted Human Reproduction Act
• Sperm and ova error or accident investigation report form (FRM-0447)